Determination of Non-applicability (24II)

July 16, 2024
Nancy H. Worthington
[email protected]
RE:

Approval of Exempt Research Protocol 7503, “Overdose prevention services for people
experiencing homelessness”

Dear Nancy H. Worthington:
On July 16, 2024, the CDC Human Research Protections Office (HRPO) reviewed your submission
of research study, “Overdose prevention services for people experiencing homelessness,” and has
determined that it meets the criteria for exemption under 45 C.F.R. 46.104(d)(2)(ii). Therefore,
HRPO approved your research study for exemption, and assigned it CDC Protocol Number 7503.
Please note that a Certificate of Confidentiality (COC) applies to this study, and the recommended
COC language has been added to the study’s protocol and informed consent form.
If the research is not complete within one year, you must submit Form 1259, Study Progress Report
form, by July 15, 2025, to maintain exempt status for the research. Any changes to this protocol may
not be implemented until they are reviewed by HRPO and determined to be consistent with the
exemption categories.
Please note that investigators remain responsible for the ethical conduct of this research and for
ensuring appropriate human research protections even for research that is exempt from the
regulations governing the protection of human subjects in research.
If you have any questions, please contact your Associate Director for Science, your National Center
Human Subjects Contact, or me via email at [email protected], or telephone at 404-639-8379.
Sincerely,

Robert Chirila, Lead
Human Research Protections Office
cc:

Karen Angel
[email protected]